FDA 21 CFR Part 11 Audit and Assessments; we are ready when you are! Call +1 (888) 896-7580 today.
Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With electronic records widely used in the Life Sciences industry, most companies will find FDA 21 CFR Part 11 applicable.
Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA.
Part 11 helps companies safely maintain data securely so that it is not lost or corrupted, ensures companies are implementing systems and software correctly, makes sure there are data-trace changes, and prevents falsified records.
The professionals at Lazarus Alliance are completely committed to you and your business’ FDA 21 CFR Part 11 audit success. Regardless of whether you represent the private sector or the public sector, we stand ready to partner with your organizations.
Why Work With Lazarus Alliance For An FDA 21 CFR Part 11 Audit?
The Lazarus Alliance FDA 21 CFR Part 11 compliance assessment audit and readiness gap assessment services help organizations ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures and that those functions are in conformance with the requirements of 21 CFR Part 11 compliance.
Lazarus Alliance's cyber security audit professionals evaluate an organization's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 compliance assessment determines the effectiveness of an organization's process within a highly regulated environment and suggests appropriate remedial actions as necessary.
Our Cybervisors will proactively and collaboratively identify risk exposures that threaten your organization.
Our audit delivery tool, Continuum GRC, streamlines the audit process, helps reduce the complexity of compliance efforts, and gives our clients the ability to combine multiple audit frameworks into one audit.
Lazarus Alliance’s primary purpose is to help organizations attain, maintain, and demonstrate compliance and information security excellence – in any jurisdiction. Lazarus Alliance specializes in IT security, risk, privacy, governance, cyberspace law and FDA 21 CFR Part 11 audit compliance leadership solutions and is fully dedicated to global success in these disciplines.
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Just the facts ...
The FDA 21 CFR Part 11 compliance in the United States focuses on six critical areas:
- Impact of 21 CFR Part 11 on the organization's computer systems, including Quality Management Systems
- Identification of the organization's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of organizational procedures
- Analysis of procedural documentation, validation, and audit data
- Regulatory significance of the computer systems
Additionally, if operating in the European Union, the FDA 21 CFR Part 11 Annex 11 Good Manufacturing Practice (GMP) for the quality and compliance of computerized data systems that manufacture pharmaceuticals and medical devices applies. Annex 11 applies to all systems used where GMP regulations apply; when automated systems replace manual operations, there should be no resultant decrease in product quality, process control or quality assurance, and no process-related risks.
The FDA 21 CFR Part 11 Annex 11 compliance in the European Union focuses on six critical areas:
- Impact of 21 CFR Part 11 on the organization's computer systems, including Quality Management Systems
- Identification of the organization's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of organizational procedures
- Analysis of procedural documentation, validation, and audit data
- Regulatory significance of the computer systems
Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA. Companies that comply with Annex 11 manufacture products made or sold in the European Union to address the increasingly digital environment in which electronic programming can replace human judgment.
Lazarus Alliance gives our organizational clients an unmatched, in-depth, and thorough inspection of their systems and procedures. We ensure compliance with the requirements of FDA 21 CFR Part 11 through our years of experience and usage of the Continuum GRC Risk Assessment and Management SaaS that are unique to you and your company's needs.